Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conduction system pacing.
- Who it may be relevant to
- Registry conditions: Conduction System Pacing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique. There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker. Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).
Interventions
- Device Conduction system pacing
Conduction system pacing (His Bundle Pacing or Left Bundle Branch Area Pacing)
Primary outcome measures
- Freedom from major adverse events [Time frame: 24 months]
Secondary outcome measures (7)
- LVEF (%) [Time frame: 24 months]
- AF incidence [Time frame: 24 months]
- Heart Failure Hospitalization Incidence [Time frame: 24 months]
- CSP Threshold during pacemaker check (Volt @ ms) [Time frame: 24 months]
- Paced QRS width [Time frame: 24 months]
- Interventricular dyssynchrony parameters [Time frame: pre-discharged]
- Intraventricular dyssynchrony parameters [Time frame: pre-discharged]
Eligibility criteria
Inclusion criteria
- Patient who had undergone conduction system pacing attempt
- Age > 18 yo
- Capacity to understand the nature of the study, legal ability and willingness to give informed consent
Exclusion criteria
- Patient under guardianship, trusteeship, or legal protection.
- Pregnant woman (positive urine pregnancy test) or breastfeeding or lack of proven effective contraception (according to the WHO definition) or menopausal without confirmed diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 10 centers
- CHU Caen — Caen
- CHI Elbeuf — Elbeuf
- Groupe Hospitalier La Rochelle Ré-Aunis — La Rochelle
- CH Le Havre — Le Havre
- CHU Lille — Lille
- Hôpital Saint Philibert — Lomme
- CHU Rennes — Rennes
- Rouen University Hospital — Rouen
- … and 2 more centers
Identifiers
NCT: NCT06088927 · 2020/0417/OB